Pello
4mm Angled 15 Degree Diamond Bur
5manufacturers in China registered for this device type
4catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Zonefly Medical Devices Co., Ltd. | Danyang | Jiangsu | Specification developer | 7 |
| Guizhou Zirui Technology Co., Ltd. | Tongzi County, Zunyi | Guizhou | Manufacturer | 4 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | EQJ |
| Device type | Bur, Ear, Nose And Throat |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4140 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-11-13 |
| Record revised | 2025-02-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 10 to 27 °C; Storage environment humidity 10 to 75 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 30 to 75 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -20 to 40 °C |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 629051214015 | In distribution | |
| 629051214070 | In distribution | |
| 629051204015 | In distribution | |
| 629051204070 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bur, Ear, Nose And Throat | Medtronic Xomed, Inc. | 413 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 99 |
| Diego Elite | Gyrus Acmi, Inc. | 97 |
| Jedmed | Jedmed Instrument Company | 88 |
| Diego | Gyrus Acmi, Inc. | 56 |
| RAD® | Medtronic Xomed, Inc. | 53 |
| Invotec ENT Bur | Invotec International, Inc. | 50 |
| NSK Sterile Burs/Drills | Nakanishi Inc. | 46 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 41 |
| Bur, Ear, Nose And Throat | Karl Storz GmbH & Co. KG | 39 |
| Medline | Medline Industries, Inc. | 36 |
| Tricut® | Medtronic Xomed, Inc. | 31 |
Showing 12 of 646. All products under Bur, Ear, Nose And Throat
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161514 | 2017-01-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.